Pilot programmes between EMA, FDA and TGA a success

Generics/General | Posted 19/08/2011 post-comment0 Post your comment

Two pilot programmes of collaboration on inspections between EMA, FDA and the Australian Therapeutic Goods Administration (TGA) have concluded successfully, according to two reports published by the EMA on 2 August 2011. The two programmes were carried out with the intention of increasing international regulatory collaboration in order to increase drug quality and safety.


One pilot programme carried out between EMA and FDA focussed on good clinical practice (GCP). Under the joint GCP inspection pilot, the two agencies exchanged more than 250 documents relating to 54 different medicines and organised 13 collaborative inspections of clinical trials. According to EMA, ‘this lays the foundation for a more efficient use of limited resources, improved inspectional coverage and better understanding of each agency’s inspection procedures.’ The joint inspections could also help to protect participants in clinical trials and better ensure the integrity of data submitted as the basis for drug approvals.

The other pilot programme focussed on active pharmaceutical ingredients (APIs) and was carried out jointly by EMA, France, Germany, Ireland, Italy, UK, the European Directorate for the Quality of Medicines and HealthCare, FDA, and Australia’s TGA. The participants shared their API surveillance lists over a 24-month period and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and nine joint inspections.

The agencies announced that this has been a ‘positive experience’ and have therefore agreed to continue with their collaboration on inspections, taking into account the experiences and lessons learned during the pilot phases.

These are not the only collaborations being carried out between EMA and FDA. The agencies launched a three-year pilot programme on 1 April 2011 that will allow parallel evaluation of quality elements, known as Quality by Design, of selected applications that are submitted to both agencies at the same time.

Related article

EMA, FDA and TGA joint GMP inspection programme

Source: EMA

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